PregnancyNCT05412238
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
A study testing micro-and macro-nutrients fortified sachets in people with Pregnancy and Childhood, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
The aim of the present study is formulation and production of sachets containing macronutrients and micronutrients to enrich food at home and evaluate its effectiveness on pregnant mothers and children aged 6 to 60 months living in Sistan and Baluchestan province Read more about this study
- Who is it for?
- Ages 6 months to 40 yearsHealthy volunteers can take part
- What is being tested?
- micro-and macro-nutrients fortified sachets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Sep 2022to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women
- being in the first trimester of pregnancy
- free of chronic diseases before pregnancy
- no intention to change residence until delivery
- Children 6 to 23 months
- age 6 to 7 months
Show all 12Show fewer
- no intention to change residence or migrate in the next 12 months
- free of acute or chronic illness
- Children 2 to 5 years (60-24 months)
- age 24 to 48 months
- no intention to change residence or migrate in the next 6-12 months
- free of acute or chronic diseases
Who cannot join
- Pregnant women
- premature termination of pregnancy
- change of residence before delivery
- Children 6 to 23 months
- -change of residence before delivery
- Children 2 to 5 years (60-24 months) -change of residence before delivery
Trial locations and contacts
1 site in 1 country.
Iran1 site
Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Tehran
About this study
Official title: Formulation and Production of Macro- and Micronutrient Sachets for Home Fortification and Evaluation of Their Efficacy on Pregnant Mothers and Children Aged 6-60 Months in Sistan Baloochestan
The aim of the present study is formulation and production of sachets containing macronutrients and micronutrients to enrich food at home and evaluate its effectiveness on pregnant mothers and children aged 6 to 60 months living in Sistan and Baluchestan province
Read the detailed description
This study is conducted in three steps. At first, fortification sachets are formulated and produced in accordance with international recommendations for micronutrients (vitamins A, D, zinc, and iron) and macronutrients for use in normal home conditions. In the second step, efficacy of fortified sachets are evaluate in three subgroups including pregnant mothers, 6-24 months and 2-5 years old children. Nutritional, anthropometrical and biochemical indices are evaluated at the beginning and after 6-9 months intervention. At the third step, costs and cost-effectiveness of the intervention in each of the studied groups in comparison with the usual program for that age group in the health care system of the country is determined.
- Being tested
- micro-and macro-nutrients fortified sachets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-and macro-nutrients fortified sachetsDietary supplement
Every subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women receiving fortification sachets | Experimental | pregnant women receive daily fortified sachets containing micro-and macronutrients for 6-9 months Receives: Dietary Supplement: micro-and macro-nutrients fortified sachets |
| 6-24 months old children receiving fortification sachets | Experimental | 6-24 months old children receiv daily fortified sachets containing micro-and macronutrients for 6-9 months Receives: Dietary Supplement: micro-and macro-nutrients fortified sachets |
| 2-5 years old children receiving fortification sachets | Experimental | 2-5 years old children receive daily fortified sachets containing micro-and macronutrients for 6-9 months Receives: Dietary Supplement: micro-and macro-nutrients fortified sachets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain during pregnancy
Weight difference at the beginning and end of pregnancy
Measured: 6-9 months
Birth weight
Measured weight (kg) at the first day of life
Measured: 6-9 months
Weight for age
Measured weight (kg) in a specific age (year)
Measured: 6-9 months
Weight for height
The ratio of weight (kg) to height(m)
Measured: 6-9 months
Secondary outcomes (8)
25-hydroxyvitamin D (nmol/L)
Fasting serum 25-hydroxyvitamin D level
Measured: 6-9 months
Hemoglobin (g/dL)
Blood hemoglobin level
Measured: 6-9 months
Serum ferritin (ng/mL)
Fasting serum ferritin level
Measured: 6-9 months
Serum zinc (microg/dL)
Fasting serum zinc level
Measured: 6-9 month
Serum retinol (micromol/L)
Fasting serum retinol level
Measured: 6-9 months
Serum folate (ng/mL)
Fasting serum folate level
Measured: 6-9 months
Serum B12 (pg/mL)
Fasting serum B12 level
Measured: 6-9 months
Apgar score
The Apgar score is a quick evaluation of one minute and five minutes after birth which tests the birthing process and readiness of newborn to meet the world without additional medical assistance
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study startSep 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute
- Investigators
- Tirang R. Neyestani, PhD, Study chair, NationalNFTI, SBMU, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412238
- Sponsor's protocol ID
- 27
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formulation and Production of Macro- and Micronutrient Sachets for Home Fortification and Evaluation of Their Efficacy on Pregnant Mothers and Children Aged 6-60 Months in Sistan Baloochestan
- ClinicalTrials.gov ID
- NCT05412238
- Acronym / sponsor ID
- 27
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is formulation and production of sachets containing macronutrients and micronutrients to enrich food at home and evaluate its effectiveness on pregnant mothers and children aged 6 to 60 months living in Sistan and Baluchestan province
Detailed description
This study is conducted in three steps. At first, fortification sachets are formulated and produced in accordance with international recommendations for micronutrients (vitamins A, D, zinc, and iron) and macronutrients for use in normal home conditions. In the second step, efficacy of fortified sachets are evaluate in three subgroups including pregnant mothers, 6-24 months and 2-5 years old children. Nutritional, anthropometrical and biochemical indices are evaluated at the beginning and after 6-9 months intervention. At the third step, costs and cost-effectiveness of the intervention in each of the studied groups in comparison with the usual program for that age group in the health care system of the country is determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant women receiving fortification sachets | Experimental | Dietary Supplement: micro-and macro-nutrients fortified sachetspregnant women receive daily fortified sachets containing micro-and macronutrients for 6-9 months |
| 6-24 months old children receiving fortification sachets | Experimental | Dietary Supplement: micro-and macro-nutrients fortified sachets6-24 months old children receiv daily fortified sachets containing micro-and macronutrients for 6-9 months |
| 2-5 years old children receiving fortification sachets | Experimental | Dietary Supplement: micro-and macro-nutrients fortified sachets2-5 years old children receive daily fortified sachets containing micro-and macronutrients for 6-9 months |
Who may qualify
- Ages
- 6 months to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Pregnant women
- Children 6 to 23 months
- Children 2 to 5 years (60-24 months)
Key exclusion criteria (6 listed)
- Pregnant women
- Children 6 to 23 months
- -change of residence before delivery
- Children 2 to 5 years (60-24 months) -change of residence before delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micro-and macro-nutrients fortified sachetsEvery subject receives daily fortified sachets containing micro-and macronutrients for 6-9 months | Dietary supplement | 2-5 years old children receiving fortification sachets, 6-24 months old children receiving fortification sachets, Pregnant women receiving fortification sachets |
Primary outcome
Weight gain during pregnancy
Time frame: 6-9 months
Weight difference at the beginning and end of pregnancy
Birth weight
Time frame: 6-9 months
Measured weight (kg) at the first day of life
Weight for age
Time frame: 6-9 months
Measured weight (kg) in a specific age (year)
Weight for height
Time frame: 6-9 months
The ratio of weight (kg) to height(m)
8 secondary outcomes
25-hydroxyvitamin D (nmol/L)
Time frame: 6-9 months
Hemoglobin (g/dL)
Time frame: 6-9 months
Serum ferritin (ng/mL)
Time frame: 6-9 months
Serum zinc (microg/dL)
Time frame: 6-9 month
Serum retinol (micromol/L)
Time frame: 6-9 months
Serum folate (ng/mL)
Time frame: 6-9 months
Serum B12 (pg/mL)
Time frame: 6-9 months
Apgar score
Time frame: 6-9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tirang R. Neyestani, PhD study chair
NationalNFTI, SBMU, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro-and macro-nutrients fortified sachets in people with Pregnancy and Childhood, run by National Nutrition and Food Technology Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tirang R. Neyestani, PhD (982122376471, neytr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain during pregnancy (time frame: 6-9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.